Sterile Production Supervisor (2nd shift)

Job Description

Position Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations that support sterile supply, aseptic formulation, aseptic filling, and visual inspection.

This role require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects.  Positions may also support commissioning, qualification, and demonstration of new equipment and technologies.  Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline. 

Accountability

• First line operations supervisor with a team of individual contributor production direct reports

• Ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP), safety, etc.

• Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.

• Tactical and strategic shift management, including collaboration with indirect staff

• Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.

• Promote the behaviors and principles that drive continuous improvement 

Duties

• Coordinates and supervises the daily activities of individual contributors.  Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives.

• Identifies and resolves standard day to day quality, technical, and operational problems within own unit.  Makes decisions – guided by policies and standard operating procedures – that impact the efficiency and effectiveness of own unit.  Receives guidance and oversight from the Operations Director.

• Works within budgetary/financial objectives set by Director 

• Compliance – Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need. 

• Supply – Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).

• Continuous Improvement – Accountable for developing a our Company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans. Report Shift(s) monthly metrics and any action plans to address gaps to Management. Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability and eliminate waste.

• People Management – Responsible for creating and sustaining a highly engaged workforce through utilization of our Company ​ Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management. 

• Position may require work outside of routine hours (e.g. nights / weekends), depending on business needs.

Core Skillsets

• Aseptic experience: Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.

• Ability to develop and lead others.

• Ability to be flexible and understand risk.

• Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies.

• Continuous improvement